Dr. Timothy Scott
See book keywords and concepts |  Davidson, the lead author, also holds stock in Pfizer, American Home Products, glaxosmithkline, Procter and Gamble, and Triangle Pharmaceuticals; has received speaker fees from Solvay, Pfizer, glaxosmithkline, Wyeth-Ayerst, Lichtwer, and the American Psychiatric Association; has been a scientific advisor to Allergan, Solvay, Pfizer, glaxosmithkline, Forest Pharmaceuticals, Inc. | | Changes May Be Coming
I discussed in the Tricks of the Trade chapter the lawsuit Eliot Spitzer brought against glaxosmithkline for hiding the results of studies which found their antidepressant to be associated with suicide. I did not mention that Mr. Spitzer was not just upset with glaxosmithkline. "Where has the FDA been all these years when clinical data has been hidden from public scrutiny? They have simply failed to confront the problem."59
It is truly remarkable what media attention can accomplish. |
Andreas Moritz
See book keywords and concepts |  The manufacturer, glaxosmithkline, has predicted that 5 million to 6 million Americans a year will buy the drug, which may be true, given the 70 million Americans who resolve to lose weight by going on a diet program. The drug blocks the absorption of about 25 percent of consumed fat. That would eliminate about 225 calories from a 3,000 calorie per day diet, in exchange for loose stools and gas with an oily discharge. | | An analysis pooling the results of several dozen studies, encompassing some 28,000 patients, showed that Avandia, which is manufactured by glaxosmithkline, causes a 43 percent higher risk of heart attack. The U.S. government has issued a safety alert, but despite the enormous health risk imposed by the drug, the FDA has not requested a stronger warning label for the drug. I dare raise these simple questions: "Is it any wonder that 80 percent of diabetics die of heart disease?" "And who benefits from downplaying these known and proven risks? |
Charles Barber
See book keywords and concepts |  When asked why glaxosmithkline went ahead with campaigns promoting depression and antidepressants, the Japanese product manager for Paxil explained: "When other pharmaceutical companies were giving up on developing antidepressants in Japan, we went ahead for a very simple reason: the successful marketing in the United States and Europe. | | The initiative came about as a result of gifts from Pfizer, Lilly, glaxosmithkline, AstraZeneca, Bayer, Procter & Gamble, and Wyeth-Ayerst.90
While the public, historically, has been innocently unaware of these details, they are starting to get wise. In the public's view, the pharmaceutical industry has recently joined the oil industry as the most exploitative and reviled sector of corporate America. The perception of manipulation and arrogance on the part of Big Pharma is starting to stick. A trust factor appears to have been violated. | | High-profile confessors of recent years include Jane Pauley, whose revelation of bipolar disorder in a book and TV special was timed with the launch of her daytime talk show, and three-time Grammy winner Shawn Colvin, whose tour was sponsored by glaxosmithkline, the makers of the folksinger's antidepressant of choice, Wellbutrin XL. The favored confessional platform is The Oprah Winfrey Show, where celebrities like Colvin and Linda Hamilton, the tough female action star of The Terminator movies, divulge their inner torments on shows called "Depressed, Mentally 111, and Famous. | | It's one thing to say, at the office holiday party, that you have social anxiety disorder; it's quite another to say you have social anxiety disease. Had glaxosmithkline been marketing Paxil for generalized anxiety disease, it would have been a much harder sell. The ads on prime-time TV would have been much more distasteful.
The use of disease as the prevailing term for psychiatry, while in my view a vast improvement, would not always be appropriate. Disease can connote contagion, not relevant to psychiatry, and is also associated with viral conditions. |
Bill Sardi
See book keywords and concepts |  Four other pharmaceutical companies in early stages of development of p38 blockers include Vertex Pharmaceuticals,
10
Inc., glaxosmithkline, Sankyo and ArQule. The chief financial officer of SCIOS says: "This is a very tight race. We don't intend to be second." [Reuters, Jan 7, 2002]
Advancing age increases the production of the p38 kinase inflammatory enzymes. [Mechanics Ageing Dev 123: 881-90, 2002] Dietary salt also increases the production of p38 kinase enzymes. |
Charles Barber
See book keywords and concepts | | In response, Glaxo-SmithKline positioned Paxil as an antianxiety drug, and on April 16, 2001, got their prize: FDA approval as an agent for "generalized anxiety disorder," previously a little-known condition. glaxosmithkline cranked up an aggressive public relations campaign—an amalgam of profiles of generalized anxiety sufferers given out to local news programs, patient surveys meant to inform the populace of the hidden epidemic, expert testimony by eminent psychiatrists, a blizzard of newspaper articles, and, most pointedly, an onslaught of DTC ads on television. |
Mike Adams, the Health Ranger
See article keywords and concepts |  On news of the FDA's vote, stock prices of glaxosmithkline LLC made the highest jump in two years. Business analysts noted the victory for Glaxo: "At 22-1, this was a clear endorsement of the product," said Peter Cartwright at Evolution Securities in London. "They've strengthened the label. Now Glaxo can get back on the road." And the FDA can get back to business killing people while pretending to be protecting them.
The truth, friends, is that nobody needs Avandia. Type-2 diabetes can be easily reversed in just three weeks (50% success rate) by simple changes in diet and lifestyle. |
Mike Adams, the Health Ranger
See article keywords and concepts |  When it comes to weight loss, consumers are looking for a magic bullet -- a miracle pill that eliminates the responsibility of having to actually make adult decisions about their own health. glaxosmithkline has delivered the pot-of-weight-loss-gold at the end of the rainbow in the form of an over-the-counter drug called, "Alli."
Alli is bound to be a huge market success. |
Mike Adams, the Health Ranger
See article keywords and concepts |  As we reported in a previous NewsTarget article on Paxil:
Researchers from Cardiff University in Britain and the Cochrane Centre examined data on Paxil -- or its generic form, paroxetine -- from glaxosmithkline, legal cases and emails from nearly 1,400 patients who responded to a British TV program on antidepressants. The researchers found that 60 out of 9,219 people taking Paxil -- 0.65 percent -- experienced a "hostility event," compared to 20 out of 6,455 patients taking placebo, or 0.31 percent. |
Bottom Line Health
See book keywords and concepts | | Drug maker glaxosmithkline plans to market the shot as Streptorix. The vaccine is undergoing Phase 3 trials, the final set of tests that is needed to seek approval for marketing a pharmaceutical product.
Breakthrough Vaccines: Meningitis, Whooping Cough
David Neumann, executive director, National Partnership for Immunization.
Paul Offit, MD, chief of infectious diseases, The Children's Hospital of Philadelphia.
Health experts are recommending that children receive breakthrough vaccines for meningitis as well as for whooping cough {pertussis). |
Shannon Brownlee
See book keywords and concepts |  That year, New York's then—attorney general, Elliot Spitzer, sued glaxosmithkline (SmithKline merged with Glaxo in 2001) for concealing data on the drug's potential to cause suicide. Internal company documents that became public included a memo to company sales reps that instructed them specifically not to discuss the potential suicide risk with physicians. Other company research suggested that as many as one in four patients on Paxil suffer withdrawal symptoms if they abruptly stop taking the drug. |
Charles Barber
See book keywords and concepts | | As part of an earlier campaign for "social anxiety disorder" ("Imagine Being Allergic to People" was the slogan), glaxosmithkline spent $92 million in one year to market Paxil—more than Nike spent to market its top shoes.100 The result of all this: Paxil passed Prozac and Zoloft and became the world's ninth best-selling drug.101
The marketing has been so excessive that the drug companies clearly took advantage of the events of September 11 for sales. Even Psychiatric News, a journal of the American Psychiatric Association, said that drug makers like Glaxo found 9/11 "a marketing opportunity. |
Melody Petersen
See book keywords and concepts |  The drug companies also copied some of RJR's direct marketing techniques. glaxosmithkline, the maker of Wellbutrin, had "Racing for Life" trailers at the track where fans were screened for depression and other diseases. An added attraction at the trailer was a visit from Bobby Labonte, the driver of the No. 18 Wellbutrin car, and his crew chief, Michael "Fatback" McSwain.
NASCAR lovers are among the most dedicated of sports fans. They are known to show their loyalty by buying the products sponsoring their favorite drivers. Mark Martin and his No. | | One of the other doctors practicing in her office had received payments from glaxosmithkline and three other drug companies. There was nothing unusual about this. It was simply an example of a tiny strand of the ubiquitous web of doctors that the drug companies had created to promote their products even when they were not around.
I rummaged through my files to find the brochure Dr. Reed had handed out to the women at the mall. Called the Headache Impact Test, it included six brief questions to use to rate the severity of headaches. |
Mike Adams, the Health Ranger
See article keywords and concepts | | But FDA officials already knew that; indeed the drug's maker, glaxosmithkline LLC, based in London, told the agency of the risk two years ago. However, the FDA failed to pass along the warning to the one million Americans who already take the drug.
Even within the FDA, scientists have presented the risks of Avandia to colleagues and fellow committee members. Dr. David Graham, a drug safety officer with the FDA's Office of Surveillance and Epidemiology, estimates that Avandia has caused as many as 205,000 heart attacks and strokes, some of them fatal, between 1999 and 2006. |
Melody Petersen
See book keywords and concepts | | He also sat on the advisory boards of glaxosmithkline, Sanofi-Synthelabo, and Solvay.
Many Iowa physicians learned about Zelnorm from Dr. Rao, even before the drug was approved in 2002. Dr. Dean Abramson, a gastroenterol-ogist with a private practice in Cedar Rapids, said that after listening to a talk by Dr. Rao, he came to believe that Zelnorm would be some kind of wonder drug. But when the drug finally gained federal approval, he was deeply disappointed in how it worked for his patients. | | Likewise, few people knew they could be suffering from something called generalized anxiety disorder if they worried too much until glaxosmithkline told them that a pill called Paxil would ease its symptoms. And in 2000 millions of women learned they might suffer from something called premenstrual dysphoric disorder, or simply PMDD. News reports of the disorder began just as marketers at Eli Lilly repackaged Prozac in a lavender and pink capsule, renamed it the sweeter-sounding Sarafem, and began selling it to treat this new disease. | | The attorney general sued the company, now known as glaxosmithkline, for fraud. Spitzer charged that the company was earning tens of millions of dollars a year from Paxil prescriptions written for children even as it concealed studies that showed it did not help them and might even make them worse.
Spitzer pointed out that the company had schooled its legions of salespeople on the purported benefits of giving the drug to teenagers. |
J. Douglas Bremner
See book keywords and concepts |  Indeed, according to a 2003 report in the New York Times, "GlaxoSmithKline and Bayer, the comarketers of Levitra, boldly admit that they are focusing on men who may have successful sexual relationships but who simply want to improve the quality or duration of their erections."
This statement upset the makers of Viagra so much that Pfizer spokeswoman Janice Lipsky told Times reporter Gardiner Harris that Levitra had benefited from "false claims and public relations in which they inaccurately state that Levitra works faster and is better, neither of which is true. |
Peter Rost
See book keywords and concepts |  Perhaps it shouldn't be surprising to know that when shareholders questioned GlaxoSmithKline's CEO about his pay package in 2003, Jean-Pierre Gamier proudly declared to the press, "I am not Mother Teresa."18 In fact, this company has a long history of getting in trouble with the law. Back in 1997, one of the companies that later formed glaxosmithkline paid $325 million to resolve federal and state fraud claims alleging overcharges to the Medicare, Medicaid, and other health care programs, one of the two largest False Claims Act settlements of that time. |
Melody Petersen
See book keywords and concepts | | Only a little more than half the patients taking Imitrex, a triptan sold by glaxosmithkline, felt relief from their pain after two hours, according to trials the company performed to get the drug approved. Even the sugar pills worked well in these studies. About a quarter of the people getting the placebo were also relieved of their pain after two hours.
Dr. Reed also did not talk about the triptans'possible side effects, which include rare heart attacks and strokes. If the risks were listed on one of her slides, she did not point them out, and they passed without notice. |
Greg Critser
See book keywords and concepts |  These mergers instead turned out to be team-wrecking, momentum-slowing, lab-shattering experiences in most big companies, glaxosmithkline chief among them. There, the cupboards were bare. Lab heads are at odds, and such high-tech industry cure-alls as high-throughput screening — computerized drug candidate testing — have been major and costly disappointments.
Yet instead of focusing on this core of issues, the industry has gone into reengineering mode. Expensive "big think" consultants are drafted by the score. Internal "change initiatives," led by overpaid managerial whizfolk, abound. |
Mike Adams
See book keywords and concepts |  The lawsuit, filed today in New York State Supreme Court in Manhattan, alleges that glaxosmithkline (GSK) engaged in repeated and persistent fraud by concealing and failing to disclose to physicians information about Paxil, a drug used to treat depression. Paxil has been approved by the FDA for the treatment of depression in adults, but not in children. Prozac is the only antidepressant that has been approved to treat depression in children. Physicians, however, have professional discretion to prescribe Paxil for treatment in children, a so-called "off-label" use. |
Peter Rost
See book keywords and concepts | | It didn't take long until both PhRMA and glaxosmithkline had declined to participate. Equipped with poor arguments, this was a no win situation for them. No one could locate Dr. Angell. So that left me alone.
Kicked Out of CNBC's Waiting Room
While preparation for the DC press conference took place, I was getting more attention from the press. For the first time in my life, television stations started calling. The first call was from Bianna Golodryga, producer for CNBC. She said that Maria Bartiromo wanted to interview me for about ten minutes the following day. |
Kelly Patricia O'Meara
See book keywords and concepts |  To the layman, what the New York attorney general was alleging was that glaxosmithkline knew Paxil was neither safe nor effective in treating depression in the adolescent population and, in fact, "engaged in deceptive, fraudulent and unlawful practices" to push the sale of the drug. Spitzer's complaint is not to be missed, and the following are just a few points he uses to make his case.
• GSK has misrepresented information concerning the safety and efficacy of paroxetine for treating MDD in children and adolescents. |
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